Tag: recall

The January recall of 48 Medtronic CRT-D and ICDs has now been expanded to include 752 additional devices at lower risk than those involved in the January recall,. There is an issue that occurred during the manufacturing process of these devices which could result in an unexpected loss of device functionality. If you have one of these devices, you should contact your doctor to discuss next steps.

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Medtronic has recalled a small number of ICDs and CRT-D devices. A total of 48 devices implanted in patients may contain a manufacturing defect which would prevent the device from delivering an appropriate shock if needed.

This is a Class I recall, which is the most serious as determined by the FDA.

Physicians of record of those affected by the recall should have already been notified by Medtronic.

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St. Jude Medical announced today that as many as 400,000 of its Fortify, Fortify Assura, Quadra Assura, Unify, Unify Assura and Unify Quadra implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices manufactured prior to May 23, 2015 are subject to a recall notice due to a risk of premature battery depletion which may render the device unable to deliver a life saving shock.

According to the FDA, the patients most at risk are those who require lifesaving shocks and those who are pacemaker dependent.

The problem has so far resulted in two deaths.

Patients with these devices should contact their physicians for advice about how to proceed, and should seek immediate medical attention if they hear a low-battery alert from their Merlin monitoring device. Continue reading “St. Jude Medical ICD Recall”→

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What is HCM?

HCM is a very common condition, and may affect as many as 1 in 200 people. However, many do not know that they have the disease and are often undiagnosed or have instead been misdiagnosed with other conditions.

The scariest thing about HCM, and the most sensational, is that HCM can sometimes cause sudden death, and this can occur without obvious symptoms beforehand.

Luckily, recent research has shown that with the right treatment, and thanks to modern medical advances, the scariest and worst scenario is not likely, and that most HCM patients will live normal life spans with few disabilities.